Search Results

Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); and Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) - Extended Cuff, is a sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

These gloves were tested for use with chemotherapy drugs and fentanyl citrate as per ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.

Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) and Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) – Extended Cuff, are disposable, single-use, sterile, blue-colored, and powder-free examination gloves made from nitrile latex.

The provided FDA 510(k) clearance letter pertains to medical examination gloves, not an AI-powered medical device. Therefore, the document does not contain information about the acceptance criteria and study proving an AI device meets those criteria.

The information typically found in such a submission would include:

• Device performance: This document explicitly states the "Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)" has been tested for resistance to permeation by chemotherapy drugs and fentanyl citrate as per ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
• Acceptance Criteria/Performance Data: The acceptance criteria for the gloves are based on relevant ASTM standards for physical properties, barrier integrity, and biocompatibility. The chemotherapy drug resistance is presented as "Minimum Breakthrough Detection Time in Minutes."
• Study Design (Non-Clinical): The studies are non-clinical, primarily laboratory-based physical and chemical tests compliant with recognized international and national standards (e.g., ASTM, ISO).
• Ground Truth: For these types of devices, the "ground truth" is typically defined by quantifiable physical and chemical properties measured against established standard methods (e.g., measuring milligrams of residual powder, breakthrough time of chemicals). There are no human experts, adjudication, or training/test sets in the context of AI for this type of device.

Given this, I cannot extract the information required for an AI-powered device from this document. The sections you asked for (sample size for test/training, expert qualifications, MRMC studies, standalone performance, etc.) are specific to AI/software as a medical device (SaMD) assessments and are not present in a submission for examination gloves.

However, I can summarize the acceptance criteria and reported performance for the examination gloves as provided in the document:

Acceptance Criteria and Reported Device Performance (for Examination Gloves)

This table summarizes the non-clinical acceptance criteria and the "result" or reported performance for the Sterile Nitrile Powder Free Examination Gloves.

Chemotherapy Drug and Fentanyl Citrate Permeation Results

Device Performance (Minimum Breakthrough Detection Time in Minutes)

Since the provided document is not for an AI device, the following points cannot be addressed:

• Sample sized used for the test set and the data provenance: Not applicable to a physical glove.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for gloves is based on physical/chemical measurements by laboratory technicians following standard protocols.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For gloves, it's objective physical/chemical measurements according to ASTM/ISO standards.
• The sample size for the training set: Not applicable (no AI training involved).
• How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device

Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) is a nonsterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. It is also tested to be used against Chemotherapy Drugs and Fentanyl Citrate.

Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) is a disposable single-use, non- sterile, blue-colored and powder-free examination glove made from nitrile latex. Gloves meet the specification of ASTM D6319-19 and have been tested for resistance to permeation by chemotherapy drugs and fentanyl citrate as per ASTM D6978-05(2019).

The provided text is a 510(k) Premarket Notification from the FDA for a medical device: "Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)".

This document does not describe the acceptance criteria or a study related to an AI/ML powered device. Instead, it details the testing and comparison of a physical medical device (gloves) against a predicate device, focusing on material properties, performance standards (like resistance to permeation by chemotherapy drugs and fentanyl citrate), and biocompatibility.

Therefore, I cannot extract the requested information regarding AI/ML device acceptance criteria or related studies from this document. The questions about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth, and training sets are not applicable to the type of device described in this FDA submission.

However, I can extract the acceptance criteria and performance data for the physical device as described:

1. Table of Acceptance Criteria and Reported Device Performance:

The primary performance criterion for the "Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)" is its resistance to permeation by chemotherapy drugs and fentanyl citrate. The acceptance criterion is a minimum breakthrough detection time for each substance.

Additional Acceptance Criteria and Performance Data (already met by similar predicate device or physical properties):

Ask a specific question about this device

Biodegradable Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Fusion Colour) is a non-sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. It is also tested to be used against Chemotherapy Drugs and Fentanyl Citrate.

These gloves were tested for use with chemotherapy drugs as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.

Biodegradable Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentany1 Citrate (Fusion Colour) is a disposable single-use, non-sterile, fusion-colored and powder-free examination glove made from nitrile latex.

The provided text is a 510(k) summary for the Biodegradable Nitrile Powder Free Examination Glove. It details the device's characteristics and compares it to a predicate device, focusing on non-clinical testing to demonstrate substantial equivalence.

Here's an analysis of the provided information regarding acceptance criteria and the study proving the device meets them, presented in the requested format.

1. Table of Acceptance Criteria and Reported Device Performance

The device is a medical glove, and its performance is evaluated against established ASTM and ISO standards for physical characteristics, chemical permeation, and biocompatibility.

(Note: The discrepancy for In Vitro Cytotoxicity is explicitly stated in the document as "found to be cytotoxic" while the acceptance criteria is "not cytotoxic." This indicates the device did not meet this specific acceptance criterion, but approval was still granted, implying the FDA found other evidence or risk mitigation sufficient.)

2. Sample Size Used for the Test Set and the Data Provenance

The document does not specify the exact sample sizes (e.g., number of gloves) used for each individual test (test set). It refers to the standards used (ASTM, ISO), which inherently define the testing methodology, including sample sizes for certain evaluations. However, the specific number of units tested for each parameter in this particular study is not provided in the summary.

Data Provenance: The document does not explicitly state the country of origin of the data collectors or the testing laboratories, but the applicant is "Hartalega NGC Sdn. Bhd." located in Malaysia. The tests are non-clinical (laboratory testing of the physical device), not human subject data. The testing appears to be prospective in the sense that the tests were conducted specifically to support this 510(k) submission for this new device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This section is Not Applicable to this device and study type. The "ground truth" for this medical device (examination glove) is established through standardized, objective laboratory measurements as defined by ASTM and ISO standards for physical properties, chemical resistance, and biocompatibility. There is no human interpretative "ground truth" (e.g., expert consensus on images) involved, as there would be for an AI-based diagnostic device.

4. Adjudication Method for the Test Set

This is Not Applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used in studies involving human interpretation or machine learning models where subjective assessment, diagnostic disagreement, or ground truth establishment based on expert consensus is required. The testing demonstrated here involves objective physical and chemical measurements.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

This is Not Applicable. An MRMC study assesses the performance of human readers, typically in a diagnostic setting, often with and without AI assistance. This submission describes a physical medical device (examination glove) and its non-clinical performance against established standards, not a diagnostic or AI-assisted product.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

This is Not Applicable. This is not an algorithm or AI product, but a physical examination glove.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is derived from:

• Standardized Test Methods and Protocols: As defined by ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization) standards. These standards specify how to objectively measure various properties (e.g., dimensions, tensile strength, permeation time, cytotoxicity).
• Laboratory Measurements: Direct, quantitative measurements of the glove's physical, chemical, and biological interactions according to the established standard methods.

8. The Sample Size for the Training Set

This is Not Applicable. There is no "training set" as this is not an AI/ML device. The testing described is for a physical product, not a statistical model that requires training data.

9. How the Ground Truth for the Training Set was Established

This is Not Applicable as there is no training set for this device.

Ask a specific question about this device

Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Blue) is a non-sterile disposable device intended for medical purpose that is worn on the examination between patient and examiner. It is also tested to be used against Chemotherapy Drugs.

These gloves were tested for use with chemotherapy drugs as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Blue) is a disposable singleuse, non-sterile, blue-colored and powder-free examination glove made from nitrile latex.

This document is a 510(k) Premarket Notification for a medical device: "Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Blue)". It describes the acceptance criteria and the study that proves the device meets those criteria, specifically for its resistance to chemotherapy drugs.

1. Table of Acceptance Criteria and Reported Device Performance

• Carmustine (3.3 mg/ml): 10.2 minutes
• Thiotepa (10.0 mg/ml): 30.2 minutes
• All other 31 listed chemotherapy drugs (e.g., Cisplatin, Cyclophosphamide, Doxorubicin, Fluorouracil, Methotrexate, Paclitaxel, etc.): >240 minutes
  Note: A caution explicitly warns against use with Carmustine and Thiotepa due to the shorter breakthrough times. |
  | Freedom from holes (ASTM D5151-19 and ASTM D6319-19) | AQL 1.5% | Pass |
  | Residual Powder (ASTM D6124-06 (2017)) | Average less than 2 mg/glove | Pass |
  | Dimensional Conformance (ASTM D6319-19) | Conforms to ASTM D6319 width, thickness, and length requirements for XS, S, M, L, and XL (AQL 4%)
  • Length: ≥ 230 mm
  • Width (XS: 70 ± 10 mm, S: 80 ± 10 mm, M: 95 ± 10 mm, L: 110 ± 10 mm, XL: 120 ± 10 mm)
  • Palm Thickness: Min 0.05 mm
  • Finger Thickness: Min 0.05 mm | Pass (Meets specified length, width, palm thickness, and finger thickness requirements. The document specifically states for length "≥ 230 mm" for the subject device and "≥ 240 mm" for the predicate, but both are considered "Same" with a combined ASTM D6319-19 approval) |
    | Tensile Performance (ASTM D6319-19) | Conforms to ASTM D6319 tensile strength of at least 14 MPa and ultimate elongation of at least 500% requirements prior to aging, and tensile strength of at least 14 MPa and ultimate strength of at least 400% after accelerated aging (AQL 4%) | Pass |
    | Biocompatibility: Skin Irritation (ISO 10993-10) | Under the conditions of the study, not an irritant. | Pass (Under the conditions of the study, the device is not an irritant) |
    | Biocompatibility: Skin Sensitization (ISO 10993-10) | Under the conditions of the study, not a sensitizer. | Pass (Under the conditions of the study, the device is not a sensitizer) |
    | Biocompatibility: Acute Toxicity (ISO 10993-11) | Under the conditions of the study, no acute systemic toxicity. | Pass (Under the conditions of this study, the device showed no evidence of acute systemic toxicity) |

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the specific sample sizes used for each test set within the provided tables (e.g., how many gloves were tested for holes, or how many individual glove samples were exposed to each chemotherapy drug). However, it indicates compliance with recognized standards (ASTM D5151-19, ASTM D6319-19, ASTM D6124-06, ASTM D6978-05). These standards typically specify the minimum sample sizes required for testing.

The data provenance is implied to be prospective testing conducted by the manufacturer (Hartalega NGC Sdn. Bhd.) to meet the requirements for their 510(k) submission. Given the company's address, the testing was likely conducted in Malaysia or an affiliated testing facility.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable as the evaluation of the device's performance against physicochemical and biological standards (like chemical permeation, physical properties, and biocompatibility) does not typically involve human experts establishing ground truth in the way a clinical diagnostic study would. The "ground truth" here is defined by the objective metrics and thresholds established by the ASTM and ISO standards.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving human interpretation or subjective assessments to resolve discrepancies. The tests described are objective, standardized laboratory tests.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. The device is an examination glove, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is entirely irrelevant to this device.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. The device is a physical medical device (glove), not an algorithm or software. Standalone algorithm performance refers to the assessment of an AI system without human intervention, which does not apply here.

7. The Type of Ground Truth Used

The ground truth used for performance assessment of the Nitrile Powder Free Examination Glove is based on objective, standardized laboratory test results and their comparison against pre-defined acceptance criteria set by international standards:

• Chemotherapy Drug Permeation: Measured breakthrough times (in minutes) as per ASTM D6978-05 (Reapproved 2019). The standard itself establishes the methodology and criteria for evaluating resistance.
• Physical Properties: Measurements against specifications outlined in ASTM D5151-19 (freedom from holes), ASTM D6319-19 (dimensional conformance, tensile performance), and ASTM D6124-06 (R17) (residual powder).
• Biocompatibility: Results of tests performed according to ISO 10993-10 (skin irritation, skin sensitization) and ISO 10993-11 (acute systemic toxicity), which define the methods and expected outcomes for non-toxic materials.

8. The Sample Size for the Training Set

This is not applicable. The device is a manufactured product undergoing standardized testing, not a machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This is not applicable for the same reason as point 8.

Ask a specific question about this device

Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs is intended to be worn by operating room personnel to protect surgical wound from contamination. It is also tested for use against Chemotherapy Drugs.

The gloves were tested for use with chemotherapy drugs as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.

Please note that Carmustine and Thiotepa have extremely low permeation times of 12.3 minutes and 17.4 minutes respectively.

Warning: Do not use with Carmustine and Thiotepa

Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs is a disposable single-use, sterile, natural-colored and powder-free surgical glove made from synthetic polyisoprene latex.

The provided documents describe the acceptance criteria and performance of the Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs. This is a medical device, and the information is presented as part of an FDA 510(k) premarket notification.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The core of the acceptance criteria and device performance is detailed in the "TECHNOLOGICAL CHARACTERISTICS COMPARISON TABLE" and the "SUMMARY OF NON-CLINICAL TESTING" sections.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the specific sample sizes for each test in the "test set" (i.e., the data used to prove the device meets acceptance criteria). However, it lists recognized industry standards (ASTM, ISO, USP) for each test. These standards typically define minimum sample sizes for testing to ensure statistical validity.

The data provenance can be inferred based on the applicant information:

• Country of Origin of the Data: The applicant is Hartalega NGC Sdn. Bhd., located in Sepang, Selangor, Malaysia. Therefore, the testing was likely conducted in Malaysia or by laboratories commissioned by the Malaysian company.
• Retrospective or Prospective: These are non-clinical (laboratory) tests performed on the device to demonstrate its properties. This would be considered prospective in the sense that the tests were specifically conducted to evaluate this new device for regulatory submission, not retrospectively analyzed from existing data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not applicable as the evaluation relies on objective, standardized laboratory tests (e.g., chemical permeation, physical property measurements, biocompatibility assays) rather than expert interpretation of a "test set" in the context of medical imaging or diagnostic algorithms. The "ground truth" is established by the defined parameters and methodologies of the ASTM, ISO, and USP standards.

4. Adjudication Method for the Test Set

This is not applicable as the evaluation relies on objective, standardized laboratory tests. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human readers and subjective interpretations, such as radiology image reviews.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "CLINICAL PERFORMANCE DATA: Not applicable. There was no clinical data required to support the subject device as the indication for use is equivalent to the predicate device." MRMC studies are used to evaluate the diagnostic performance of devices, often medical imaging AI, with human-in-the-loop scenarios. This document describes the performance of a physical medical device (surgical glove) through non-clinical testing.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

This is not applicable as the device is a physical surgical glove, not an algorithm or AI system. The tests evaluate the physical and chemical properties of the glove itself.

7. The Type of Ground Truth Used

The "ground truth" for this device's evaluation is based on established standard test methodologies and defined acceptance criteria set by organizations like ASTM, ISO, and USP. These are objective measurements:

• Physical measurements (length, width, thickness)
• Mechanical properties (tensile strength, elongation)
• Chemical resistance (breakthrough time for chemotherapy drugs)
• Biological safety (cytotoxicity, irritation, sensitization, systemic toxicity, pyrogenicity)

It does not involve expert consensus, pathology, or outcomes data in the typical sense of AI/diagnostic device evaluation.

8. The Sample Size for the Training Set

This is not applicable. This is a physical medical device, not an AI or machine learning model that requires a training set. The term "training set" refers to data used to train an algorithm.

9. How the Ground Truth for the Training Set was Established

This is not applicable for the same reason as Section 8.

Ask a specific question about this device

Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram or Less per Gram of Glove and Tested for Use with Chemotherapy Drugs is made of natural rubber intended to be worn by operating personnel to protect a surgical wound from contamination. It is also tested to be used against Chemotherapy Drugs.

These gloves were tested for use with chemotherapy drugs as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.

Not Found

This document is a 510(k) premarket notification from the FDA, specifically for a Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram or Less per Gram of Glove and Tested for Use with Chemotherapy Drugs.

The request asks for information typically found in an AI/Software as a Medical Device (SaMD) study, such as acceptance criteria, sample sizes for training and testing, expert qualifications, and MRMC studies. However, this document describes a physical medical device (surgical gloves), not an AI/SaMD.

Therefore, I cannot provide the requested information because it is not applicable to the provided document. The document details the device's intended use and performance against chemotherapy drugs, but it does not involve any AI/ML components or studies of human-in-the-loop performance with AI.

To directly answer your questions based on the provided document:

1. A table of acceptance criteria and the reported device performance:
   The acceptance criteria for chemotherapy drug permeation are implicitly defined by the "Minimum Breakthrough Detection Time in Minutes" columns, and the reported device performance is the value in that column. The standard used is ASTM D6978-05 (Reapproved 2019):

   • Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time in Minutes (Acceptance Criteria & Reported Performance)
   • Carmustine (BCNU) (3.3 mg/ml) | 12.5
   • Cisplatin (1 mg/ml) | > 240
   • Cyclophosphamide (Cytoxan) (20.0 mg/ml) | > 240
   • Dacarbazine (10 mg/ml) | > 240
   • Doxorubicin HCI (2.0 mg/ml) | > 240
   • Etoposide (20.0 mg/ml) | > 240
   • Fluorouracil (50.0 mg/ml) | > 240
   • Methotrexate (25 mg/ml) | > 240
   • Mitomycin C (0.5 mg/ml) | > 240
   • Paclitaxel (6.0 mg/ml) | > 240
   • Thiotepa (10.0 mg/ml) | 13.6
   • Vincristine Sulfate (1.0 mg/ml) | > 240
   • Note: The document also explicitly warns against using the gloves with Carmustine (BCNU) and Thiotepa due to low permeation times.

2. Sample sizes used for the test set and the data provenance: Not applicable to this type of device. The testing methodology for ASTM D6978-05 would define the sample sizes for glove permeation testing, but this is not detailed in the FDA letter. Data provenance would be from laboratory testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for physical device performance is established through standardized laboratory testing, not human expert consensus.

4. Adjudication method: Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This is for AI/SaMD, not physical gloves.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used: Laboratory test results based on ASTM D6978-05 for chemotherapy drug permeation and potentially other standards for protein labeling claims.

8. The sample size for the training set: Not applicable. This is a manufactured product, not an AI model.

9. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device

Polychloroprene Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Fusion Colour) is a nonsterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. It is also tested to be used against Chemotherapy Drugs.

These gloves were tested for use with chemotherapy drugs as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Please note that Carmustine and Thiotepa have extremely low permeation times of 14.9 minutes. Warning: Do not use with Carmustine Warning: Do not use with Thiotepa

Polychloroprene Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Fusion Colour) is a nonsterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. It is also tested to be used against Chemotherapy Drugs.

The provided document describes the FDA 510(k) clearance for a "Polychloroprene Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Fusion Colour)". This is not an AI/ML device but a physical medical device (examination gloves).

Therefore, the requested information (acceptance criteria and study details related to AI/ML device performance, ground truth, expert adjudication, MRMC studies, etc.) is not applicable to this document.

The document focuses on the glove's performance against chemotherapy drugs, as detailed in the "Indications for Use" section. It reports breakthrough times for various chemotherapy drugs based on ASTM D6978-05 (Reapproved 2019) standards.

Here's the relevant information that can be extracted from the provided text, modified to fit the closest possible interpretation of your request, even though it's not an AI/ML device:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The "acceptance criteria" here are implied by the standard ASTM D6978-05 for assessing permeation. The higher the breakthrough time, the better the performance. The document explicitly issues warnings for Carmustine and Thiotepa due to their low breakthrough times, suggesting these values did not meet an implicit desired criterion for safe use.

2. Sample size used for the test set and the data provenance:

• Test Set Sample Size: Not explicitly stated in the document. The ASTM D6978-05 standard would define the sample size requirements for testing gloves against chemotherapy drugs.
• Data Provenance: The document does not specify the country of origin of the data. The testing was conducted according to ASTM D6978-05 (Reapproved 2019), which is an American Society for Testing and Materials standard. The study is prospective in the sense that the gloves were specifically tested for this clearance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. This is not an AI/ML device where expert consensus for ground truth is typically required. The "ground truth" here is the physical measurement of chemical permeation according to a standardized test method.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not applicable. Adjudication methods are relevant for subjective interpretations, typically in AI/ML performance evaluation. The ASTM D6978-05 standard is a physical chemical test with objective measurements.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not applicable. This is not an AI/ML device; therefore, no MRMC study, human readers, or AI assistance is relevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Not applicable. This is not an algorithm or AI system. The testing describes the standalone performance of the physical glove.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• The "ground truth" for this device's performance is established by objective chemical permeation measurements obtained through standardized laboratory testing as per ASTM D6978-05.

8. The sample size for the training set:

• Not applicable. This is a physical device, not an AI/ML model that requires a training set.

9. How the ground truth for the training set was established:

• Not applicable. No training set is involved.

Ask a specific question about this device

Nitrile Powder Free Examination Gloves with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) is a non-sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. It is also tested to be used against Chemotherapy Drugs and Fentanyl Citrate.

These gloves were tested for use with chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Nitrile Powder Free Examination Gloves with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) is a non-sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

This document is an FDA clearance letter for Nitrile Powder Free Examination Gloves. It focuses on the device's substantial equivalence to predicate devices and its testing against chemotherapy drugs and fentanyl citrate. The document is primarily regulatory and does not contain information about an AI/ML device study or its performance. Therefore, I cannot provide the requested details regarding acceptance criteria and a study proving an AI/ML device meets them.

The provided text pertains to a medical device clearance for examination gloves and does not contain any information about an AI/ML device, its acceptance criteria, or a study to evaluate its performance.

Therefore, I cannot answer your request based on the provided input.

Ask a specific question about this device

Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Fusion Dark Grey) is a non-sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. It is also tested to be used against Chemotherapy Drugs and Fentanyl Citrate.

These gloves were tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Fusion Dark Grey) is a non-sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

The provided document is a 510(k) premarket notification for a medical device: "Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Fusion Dark Grey)". This document does not pertain to an AI/ML medical device and therefore does not include the typical information about acceptance criteria, study design, and ground truth establishment relevant to AI/ML products.

Instead, this document focuses on the chemical permeation resistance of the examination gloves to various chemotherapy drugs and Fentanyl Citrate. The "acceptance criteria" here relate to the minimum breakthrough detection time for these chemicals, as per a specific ASTM standard.

Here's a breakdown of the information that can be extracted from the provided text, adapted to the requested format where possible, and noting where the requested information is not applicable (N/A) for this type of device:

1. Table of Acceptance Criteria and Reported Device Performance (Breakthrough Detection Time for Chemical Permeation)

The study referenced is based on ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. The acceptance criteria are implied by the standard, where a longer breakthrough time indicates better protection. While specific 'acceptance criteria' values (e.g., "must be > X minutes") are not explicitly stated as pass/fail thresholds in this summary, the results demonstrate the performance against the standard's methodology. The crucial findings for two drugs are highlighted as warnings.

Warnings: The document explicitly states: "Please note that Carmustine and Thiotepa have extremely low permeation times of 12.9
minutes and 45.0 minutes respectively. Warning: Do not use with Carmustine. Warning: Do not use with Thiotepa." This suggests an implicit acceptance criterion where these breakthrough times are deemed insufficient for safe use, leading to a contraindication.

2. Sample size used for the test set and the data provenance:

• Sample Size for Test Set: Not explicitly stated in the provided document. The ASTM D6978-05 standard would specify the number of glove samples to be tested per drug.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The testing would have been conducted in a laboratory setting according to the ASTM standard.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This is N/A for the current device. The "ground truth" here is the measured chemical breakthrough time, determined by laboratory instruments and testing procedures defined in the ASTM standard, not by expert interpretation.

4. Adjudication method for the test set:

• This is N/A for the current device. Chemical permeation testing does not involve adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• This is N/A for the current device. This is not an AI/ML device, and no human reader study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• This is N/A for the current device. This is not an AI/ML device. The performance reported is for the physical glove material itself.

7. The type of ground truth used:

• The "ground truth" for this study is direct laboratory measurement of chemical permeation, quantified as Minimum Breakthrough Detection Time, as determined by the ASTM D6978-05 standard.

8. The sample size for the training set:

• This is N/A for the current device. There is no AI/ML model involved, hence no training set. The gloves are manufactured based on established material science and manufacturing processes, with testing conducted to verify performance characteristics.

9. How the ground truth for the training set was established:

• This is N/A for the current device, as there is no training set for an AI/ML model.

Ask a specific question about this device

Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotheraty Drugs and Fentany Citrate (Blue) is a non-sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. It is also tested to be used against Cliemotherapy Drugs and Fentanyl Citrate

Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)

This document is a 510(k) clearance letter for "Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)". It details the device's indications for use and performance related to permeation by chemotherapy drugs and Fentanyl Citrate.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

The acceptance criteria are implied by the standard ASTM D6978-05 (Reapproved 2013) and the reported minimum breakthrough detection times for various chemotherapy drugs and Fentanyl Citrate. The goal is to demonstrate that the gloves provide a protective barrier for a sufficient duration. The reported performance refers to the breakthrough times achieved during testing.

Note: The document explicitly states: "Please note that Carmustine and Thiotepa have extremely low permeation times of 21.4 minutes and 67.2 minutes respectively. Warning: Do not use with Carmustine". This implies that while the device was tested against Carmustine, its low breakthrough time means it does not meet a practical "acceptance" for safe use with that particular drug, leading to a specific warning. For other drugs, a breakthrough time of >240 minutes indicates good performance.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample size used for the test set (number of gloves or repetitions per drug). It also does not explicitly state the data provenance or whether the study was retrospective or prospective. The testing was conducted "as per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs," which is a standardized testing method.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable to this type of device and study. The "ground truth" here is the physical permeation of chemicals through the glove material, measured in a laboratory setting using analytical techniques as defined by the ASTM standard. It does not involve expert interpretation or consensus.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This study involves objective laboratory measurements, not subjective evaluations requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a study on the barrier effectiveness of gloves against chemical permeation, not an AI-assisted diagnostic study involving human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This document describes a physical performance test of a medical device (gloves), not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" is the empirically measured breakthrough time of various chemotherapy drugs and Fentanyl Citrate through the glove material, determined according to the methodologies outlined in ASTM D6978-05. This is a direct physical measurement.

8. The sample size for the training set

Not applicable. This refers to the testing of a physical medical device, not a machine learning model that requires a training set.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this type of device testing.

Ask a specific question about this device